WithdrawnNot Applicable

Intravenous Immunoglobulin in Combination Therapy With Antibacterial Agents for SSI of the Lower Digestive Tract

Stopped: No eligible patient.

Japan60 participantsStarted 2007-08

Plain-language summary

The purpose of this study is to assess the clinical usefulness of IVIG in combination therapy with antibacterial agents for severe peritonitis after lower digestive tract surgery.

Who can participate

Age range20 Years

SexALL

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Inclusion criteria

✓. Patients with \>=38 degrees C, \>=15,000/mm3 or \<=3,000/mm3 of WBC and \>=10mg/dL of CRP
✓. Patients who have no abscess on the abdominal image
✓. Patients who were administered antibacterial agents for 1 day or more, and show no sign of improvement
✓. Patients who are 20 years old or older
✓. Patients who have signed the agreement for participation in this study

Exclusion criteria

✕. Patients who have a history of hypersensitivity to any of the ingredients of Immunoglobulin products
✕. Patients who have a history of shock due to any of the ingredients of Immunoglobulin products
✕. Patients who were administered immunoglobulin within 1 month before entry
✕. Patients who were administered antibacterial agents for 1 day or more, and show signs of improvement
✕. Patients with IgA deficiency
✕. Patients with hereditary fructose intolerance
✕. Patients with history of allergy or adverse effect for antibacterial agents
✕. Patients who have underlying or concomitant disease that may seriously affect the assessment of this study

What they're measuring

clinical efficacy

Timeframe: at day 7

Trial details

NCT IDNCT00511212

SponsorMulticenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

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